EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%

Pfizer expands ‘An Accord for a Healthier World’ product offering in 45 lower-income countries

Products offered on a not-for-profit basis to the 45 lower-income countries now include the full portfolio for which Pfizer has global rights.

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions

G20: Medical Value Travel is an essential component for idealistic healthcare to address disparities of healthcare systems: Kotecha

Multilateral collaborations will serve to strengthen knowledge sharing to formulate framework for accessible, affordable, and quality healthcare

NAFLD clinical trial activity catching up in China but lacks substantial domestic participation, says GlobalData

China has the highest number of clinical trials that were initiated in NAFLD in the APAC region over the past decade.

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe

Enhertu to demonstrate a significant survival benefit vs. chemotherapy